Clinical trial · Observational
Cognitive Sequelae of Adjuvant Endocrine Therapy for the Treatment of Breast Cancer in Older Women
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Breast cancer is the most frequently diagnosed cancer in women with the majority receiving an endocrine therapy (ET) in the adjuvant setting. ETs dramatically reduce recurrence and improve survival but given the aging population and increased survivorship, there are growing concerns regarding the cognitive effects of ETs since estrogen is neuroprotective. A critical unanswered question is whether there are differences in cognitive decline between the two classes of ETs, selective estrogen receptor modulators (SERMs - tamoxifen) and aromatase inhibitors (letrozole and anastrozole), in older women at greater risk of hormone receptor breast cancer and cognitive decline. Before a large multicentre observational study can be undertaken the investigators are proposing a feasibility study to establish metrics on participation, retention and adherence rates and parameter estimates to inform sample size calculation required to detect cognitive differences between the two ET classes. A convenience sample of chemotherapy-naïve patients, aged 65 and older, with early stage disease, 25 on a SERM and 50 on an aromatase inhibitor, will be assessed cognitively at baseline and after one year.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neuropsychological test battery | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Tamoxifen
- description
- Chemotherapy-naïve women 65 and older with a first diagnosis of early stage HR+ BC, post surgical resection prescribed tamoxifen.
- interventionNames
- Other: Neuropsychological test battery
- label
- Aromatase Inhibitors
- description
- Chemotherapy-naïve women 65 and older with a first diagnosis of early stage HR+ BC, post surgical resection prescribed aromatase inhibitors.
- interventionNames
- Other: Neuropsychological test battery
Primary outcomes (1)
- measure
- The proportion of patients who experience cognitive impairment after 1 year of treatment
- timeFrame
- 1 year
- description
- Cognitive impairment will be defined as scoring at or below -1.5 standard deviations from the normative mean on two or more tests, or as scoring at or below -2.0 standard deviations on a single test.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Postmenopausal female, age 65 and older * No more than 14 weeks post surgical resection for early stage histologically confirmed hormone receptor positive (HR+) breast cancer (BC) (i.e., Tumour size 1-2, Node status 0-1, Metastasis 0). HR+ BC defined as \>1% positive cell staining * Prescribed either tamoxifen, letrozole, or anastrozole * Fluent in written and spoken English; \>grade 5 education; can read large print (with or without correction); can hear normal conversation (with or without a hearing aid) * Capacity to provide informed consent Exclusion Criteria: * Initiated adjuvant ET more than one week before baseline assessment * Chemotherapy (neoadjuvant or adjuvant) * More than one treatment of radiotherapy before baseline assessment * Hormone replacement therapy use 4 weeks prior to baseline assessment * Previous breast cancer or metastatic disease or other malignancy, other than any cancers treated for cure \>5 years ago and not having recurred except non-melanoma skin cancers; previous chemotherapy; previous use of selective estrogen receptor modulators (SERM) or aromatase inhibitor (AI); distant metastases * History of or active known CNS disease (e.g. known diagnosis of stroke, Parkinson's), medical condition impairing cognitive function, including active treatment with medication known to affect cognition, or signs of cognitive impairment on the Memory Impairment Screen * History or active known diagnosis of major psychiatric disorder in the last 10 years including bipolar disease, schizophrenia, major depression or self-reported hospitalization for psychiatric illness, alcoholism, or history of alcohol or drug abuse * Life expectancy less than two years, acutely ill or delirious
References
Publications (0)
Data not yet available